Transcatheter aortic valve replacement for severe aortic valve disease
Transcatheter Aortic Valve Replacement for Severe Aortic Valve Disease: Multi-center, Real-word Registry
This study is trying to see how well transcatheter aortic valve replacement works for people with severe aortic valve problems, especially younger patients, and what complications might occur.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05439863 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on transcatheter aortic valve replacement (TAVR) as a treatment for severe aortic stenosis and aortic regurgitation. It aims to create a prospective, multicenter database to gather real-world data addressing various clinical questions related to TAVR, such as its effectiveness in younger patients, valve durability, and complications like valve leaflet thrombosis. By analyzing this data, the study seeks to enhance understanding of TAVR outcomes and inform clinical practices.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with severe aortic stenosis or aortic regurgitation who are undergoing TAVR.
Not a fit: Patients who refuse clinical follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that improve treatment strategies for patients with severe aortic valve disease.
How similar studies have performed: Previous studies have shown that TAVR can be non-inferior or superior to surgical aortic valve replacement, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosis of severe aortic stenosis or aortic regurgitation 2. Patients undergo transcatheter aortic valve replacement Exclusion Criteria: patients refuse the clinical follow-up
Where this trial is running
Nanjing, Jiangsu
- Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Jun-Jie Zhang, MD
- Email: jameszll@163.com
- Phone: +86-25-52271350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.